# OEM: Human Metapneumovirus (Hmpv) Rna Assay System

- Device class: 2; regulation: 21 CFR 866.3980; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 29 days (middle half 29–29)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2008: 1
- 2011: 1
- 2013: 3
- 2023: 1

## Most-cited predicates
- K082688: Pro HMPV+ Assay (2008), cited by 5
- K112490: Quidel Molecular HMPV Assay (2011), cited by 1
- K123838: Pro HMPV+ Assay (2013), cited by 1

Source page: https://510kreport.com/product-code/OEM
Data by year (CSV): https://510kreport.com/product-code/OEM.csv